PRIMARY PURPOSE & ESSENTIAL JOB DUTIES:
The Quality Assurance / Regulatory Affairs (QA/RA) Specialist plays a critical role in maintaining and advancing BBCS’s Quality Management System (QMS) and regulatory compliance posture. This position supports all aspects of Quality Assurance and Regulatory Affairs activities, ensuring procedures, records, and processes meet internal quality standards and external regulatory requirements.
Working cross-functionally the QA/RA Specialist ensures quality is infused into everything we do — from SOPs and change management to CAPAs, audits, and FDA readiness. This role is ideal for a detail-oriented professional who thrives in a regulated environment and enjoys building clarity, consistency, and compliance into daily operations.
The role’s responsibilities include the following:
Quality Assurance & Document Control
- Coordinate the review, approval, and maintenance of Standard Operating Procedures (SOPs) and controlled documents.
- Partner with department managers to ensure procedures are accurate, current, and aligned with actual workflows.
- Ensure documentation formats, templates, and standards are followed consistently across departments.
- Provide document review, editing, and technical writing support to improve clarity, usability, and compliance.
- Create and revise procedures as needed to support evolving business and regulatory requirements.
- Support the BBCS document change management process and ensure proper version control.
Regulatory Affairs & Compliance
- Support FDA audit preparation, documentation, and follow-up activities.
- Assist with the preparation and organization of materials for regulatory submissions and inspections.
- Maintain working knowledge of applicable CFRs and regulatory requirements for medical device software.
- Participate in urgent device client communications (UDCC) as needed.
- Support the CAPA system, including documentation, tracking, and follow-up.
- Assist with internal quality audits and maintain associated records.
- Coordinate process failure investigations and root cause analysis.
- Support continuous improvement initiatives across the organization.
OTHER JOB DUTIES:
As an employee within BBCS, this position will participate with the other staff members to contribute to and support the corporate goals, business plan, standard operating procedures and Corporate Quality Policy, and thus requires personal and professional integrity and work ethics.
QUALIFICATIONS AND EXPERIENCE:
- Minimum of 2 years of experience in Quality Assurance, Regulatory Affairs, or document control in a regulated environment.
- Experience creating, editing, and managing SOPs and controlled documents.
- Strong technical writing and document review skills.
- Working knowledge of FDA regulations and CFR requirements preferred.
- Experience supporting CAPA systems, audits, or regulatory inspections strongly preferred.
- Experience in software development, medical device, or blood/biologics environments is a plus.
- Strong attention to detail, organization, and follow-through.
- Ability to manage multiple priorities and deadlines independently.
- Excellent verbal and written communication skills.
- Experience with Jira and Confluence a plus.
- Strong analytical, problem-solving, and collaboration skills.
EDUCATION:
Bachelor’s degree in business, technical writing, quality, regulatory, or a related field preferred or equivalent combination of education and experience.
Apply Now:
Don’t miss out on the chance to be part of something extraordinary. Apply here and join BBCS in revolutionizing healthcare technology!
